Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690776
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2022-12-19
Brief Title:
PMCF Study on the Safety Performance and Clinical Benefits Data of the Quattro X Broadband
Sponsor:
Zimmer Biomet
Organization:
Zimmer Biomet
Study Overview
Official Title:
Quattro X Suture Anchor With BroadBand Tape Post Market Clinical Follow-up Study Incl Instruments
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a multicenter retrospective and prospective non-randomized noncontrolled and consecutive series post-market study The purpose of this study is collect data confirming safety performance and clinical benefits of the Quattro X Suture Anchor with BroadBand Tape and Instruments when used in rotator cuff repair
The primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder rotator cuff Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient The clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems eg Constant Murley and EQ-5D-5L at 1 year post-operative
The safety will be assessed by monitoring the incidence and frequency of device- andor procedure-related adverse events
The primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder rotator cuff Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient The clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems eg Constant Murley and EQ-5D-5L at 1 year post-operative
The safety will be assessed by monitoring the incidence and frequency of device- andor procedure-related adverse events
Detailed Description:
The Quattro X Suture Anchor with BroadBand Tape is intended for use in rotator cuff repairs It is intended for for the reattachment of soft tissue to bone
Up to three sites will be involved in this study The aim is to include a total of 109 consecutive series cases who received the Quattro X Suture Anchor with BroadBand Tape All potential study subjects will be required to participate in the Informed Consent Process
Baseline data from the preop intraop and immediate post-op intervals will be available in medical notes and collected retrospectively During follow-up visits at 1 years post-op the patient will be asked to complete patient questionnaires Moreover a clinical assessment will be conducted In addition any complications and adverse events will also be collected during these follow-up visits
Up to three sites will be involved in this study The aim is to include a total of 109 consecutive series cases who received the Quattro X Suture Anchor with BroadBand Tape All potential study subjects will be required to participate in the Informed Consent Process
Baseline data from the preop intraop and immediate post-op intervals will be available in medical notes and collected retrospectively During follow-up visits at 1 years post-op the patient will be asked to complete patient questionnaires Moreover a clinical assessment will be conducted In addition any complications and adverse events will also be collected during these follow-up visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None